Blinatumomab

(Blincyto®)

Blincyto®

Drug updated on 4/16/2024

Dosage FormInjection (intravenous: 35 mcg)
Drug ClassCD19-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
  • Indicated for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).

Latest News

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Summary
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  • Blinatumomab (Blincyto) is indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1%, and for those with relapsed or refractory ALL.
  • Fifteen studies provide a comprehensive comparison between blinatumomab and alternative treatments, focusing on safety and efficacy for both pediatric and adult populations with ALL.
  • Anti-CD19 CAR T-cell therapy showed superior efficacy over Blincyto in relapsed/refractory acute lymphocytic leukemia. However, Blincyto was associated with lower rates of severe hematological toxicity and cytokine release syndrome (CRS), indicating a better safety profile.
  • In pediatric patients, Blincyto has demonstrated potent therapeutic efficacy with limited adverse effects compared to other available treatments for this population group suffering from relapsed/refractory B-ALL.
  • When comparing salvage therapies, such as standard chemotherapy and other immunotherapies like inotuzumab ozogamicin & CD19/CD22 dual CAR T-cells, blinatumomab is generally more favorable compared to conventional chemotherapy due to its safer profile marked by fewer serious adverse events, although it is less effective than CAR-T cell therapies.
  • Despite concerns over the long-term effectiveness and access equity related to CAR-T cell therapy, it is considered a cost-effective option based on health-economic evidence. Blinatumomab is positioned as the next best treatment option following it, especially for r/r ALL cases.
  • Blinatumomab also plays an important role before allogeneic hematopoietic stem cell transplantation, where achieving an MRD-negative state is pivotal. This can be effectively achieved using blinatumomab, making it an integral part of the therapeutic arsenal against ALL.
  • While there are potential risks associated with Blincyto, such as CRS and neurologic events, it poses a lower risk of significant adverse events compared to traditional chemotherapy in pediatric patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Blincyto (blinatumomab) Prescribing Information.2024Amgen Inc., Thousand Oaks, California

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of blinatumomab and CAR T-cell therapy in relapsed/refractory acute lymphoblastic leukemia: a systematic review and meta-analysis.2024Expert Review of Hematology
Efficacy and safety of blinatumomab in children with relapsed/refractory B cell acute lymphoblastic leukemia: A systematic review and meta-analysis.2023Frontiers in Pharmacology
Efficacy and safety of blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia: A systemic review and meta-analysis.2023Clinical Lymphoma, Myeloma and Leukemia
Comparing the efficacy of salvage regimens for relapsed/refractory B-cell acute lymphoblastic leukaemia: A systematic review and network meta-analysis.2022Annals of Hematology
Systematic review of costs and cost-effectiveness of treatment for relapsed/refractory acute leukemia in children and young adults.2022Expert Review of Hematology
The safety of blinatumomab in pediatric patients with acute lymphoblastic leukemia: A systematic review and meta-analysis.2022Frontiers in Pediatrics
Clinical pharmacology of cytotoxic drugs in neonates and infants: Providing evidence-based dosing guidance. 2022European Journal of Cancer
Blinatumomab in pediatric acute lymphoblastic leukemia-from salvage to first line therapy (A systematic review).2021Journal of Clinical Medicine
Commonly reported adverse events associated with pediatric immunotherapy: A systematic review from the Children’s Oncology Group.2021Journal of Pediatric Oncology Nursing
Evidence-based recommendations for nurse monitoring and management of immunotherapy-induced cytokine release syndrome: A systematic review from the Children’s Oncology Group.2021Journal of Pediatric Oncology Nursing
Efficacy of targeted immunotherapy as induction or salvage therapy in acute lymphoblastic leukemia: A systematic review and meta-analysis.2021Technology in Cancer Research & Treatment
A systematic review of blinatumomab in the treatment of acute lymphoblastic leukemia: Engaging an old problem with new solutions. 2021Annals of Pharmacotherapy
Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia: Results of a pooled analysis.2021Cancer Medicine
Commonly reported adverse events associated with pediatric immunotherapy: a systematic review from the children's oncology group.2020Journal of Pediatric Oncology Nursing
Efficacy and safety of bispecific T-cell engager (BiTE) antibody blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia and non-Hodgkin’s lymphoma: A systemic review and meta-analysis.2019Hematology

Clinical Practice Guidelines